51st Annual Meeting & ToxExpo - Society of Toxicology

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Society of Toxicology 2012 Scientific Symposia • The Roche Experience with the EST Assay and Development of a Novel, Fully Automated Approach. Claudia McGinnis, Hoffmann- La Roche, Basel, Switzerland. • Transcriptomics Approaches Towards Biomarkers of Embryotoxicity in the Embryonic Stem Cell Test. Aldert Piersma, National Institute for Public Health and the Environment RIVM, Bilthoven, Netherlands. • Use of Zebrafish for Identification of Targets of Teratogenicity. Hiroshi Handa, Tokyo Institute of Technology, Yokohama, Japan. • Virtual Embryo: Systems Modeling of Developmental Toxcity. Thomas Knudsen, US EPA, Research Triangle Park, NC. • ES Cell-Based Novel Alternative Testing Strategies—The ESNATS Project. Juergen Hescheler, University of Cologne, Cologne, Germany. Wednesday Aberrant Gene Expression in Toxicity and Disease—Epigenetics and microRNAs Epigenetic and miRNA Regulations in Carcinogenesis: Toxicological Implications Wednesday, March 14, 9:00 AM to 11:45 AM Chairperson(s): Jessica R. Placido, Saint John’s University, Jamaica, NY, and Enrique Fuentes-Mattei, The University of Texas MD Anderson Cancer Center, Houston, TX. Sponsor: Graduate Student Leadership Committee Endorsed by: Carcinogenesis Specialty Section Hispanic Organization of Toxicologists Special Interest Group Mechanisms Specialty Section Molecular Biology Specialty Section Postdoctoral Assembly Epigenetics is an increasingly evolving scientific field focused on mechanisms involving heritable gene expression profiles and phenotypic changes fundamental for normal development without alterations in nucleotide sequence. DNA methylation and acetylation patterns, histone modifications, germ-line reprogramming and noncoding RNAs mediate epigenetic regulations. Increasing evidence suggests that disruption and alteration of normal epigenetic regulation mechanisms are fundamental in cancer development and progression. Recent evidence shows that exposure to air toxicants and environmental pollutants triggers changes in microRNA (miRNA) expression profiles. These cellular changes reveal novel mechanisms through which toxicants may induce adverse health effects, The Thematic Track information can be found on pages 8–9. including the development of leukemia and liver carcinogenesis. In addition, arsenic has been implicated in the development of human skin, lung, bladder, liver, and prostate cancers. Histone modifications have been suggested as epigenetic mechanisms related to arsenic-induced carcinogenesis. Identification and development of new therapeutic strategies with specific and selective targets in the epigenetic machinery are of utmost importance. Recent research shows that detecting alterations in miRNA expression has been associated with early stages of tumor development. These findings suggest that miRNAs may play an important role in cancer risk assessment. Alternatively, histone deacetylase inhibitors are effective in the treatment of hematological malignancies such as leukemia in children. Epigenetic alterations that result in carcinogenesis stress the importance of research efforts to characterize associated molecular mechanisms and highlight current public health issues. • Epigenetic Effects of Formaldehyde Exposure. Julia Rager, University of North Carolina Chapel Hill, Chapel Hill, NC. • Arsenic-Induced Alterations in Global Posttranslational Histone Modifications among Adults in Bangladesh. Yana Chernova, New York University School of Medicine, New York, NY. • The Molecular and Epigenetic Mechanisms Involved in Mammalian LINE-1 Retroelement Silencing Are Altered by Benzo(a)Pyrene. Diego Elias Montoya-Durango, University of Louisville, Louisville, KY. • Epigenetic and miRNA Dysregulation in Liver Nongenotoxic and Genotoxic Tumorigenesis. Kristy Kutanzi, National Center for Toxicological Research, Jefferson, AR. • Oxidative Stress-Based Strategies for Enhancing the Efficacy of Histone Deacetylase Inhibitors (HDACi) for the Treatment of Leukemias. Nilsa Rivera-Del Valle, The University of Texas MD Anderson Cancer Center, Houston, TX. Innovations of Applied Toxicology (IAT) Session Nonclinical Safety Assessment of Dual-Targeting Biotherapeutics Wednesday, March 14, 9:00 AM to 11:45 AM Chairperson(s): Matthew S. Bogdanffy, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, and Anne Pilaro, US FDA, Silver Spring, MD. Sponsor: Biotechnology Specialty Section Endorsed by: Drug Discovery Toxicology Specialty Section Immunotoxicology Specialty Section Regulatory and Safety Evaluation Specialty Section Engineering of protein-based biotherapeutics has advanced significantly in recent years to delivering novel molecules having Thematic Session 78 SOT’s 51 st Annual Meeting
San Francisco, California The Thematic Track information can be found on pages 8–9. exceptional target specificity. Initial antibody-based therapies were designed to target a single epitope. More recently, however, multitargeting antibodies, including nanobodies, are being designed to bind and modulate multiple cellular targets having coordinated biological pathways. These novel and highly specific constructs present new challenges for assessing safety in the nonclinical setting, including identification of pharmacologically relevant species, creative study designs that support clinical development in the presence of speciesdependent pharmacokinetic behavior, and antidrug antibody assay implementation strategies for multi-anti-idiotype immunological responses that may interfere with pharmacological/toxicological data interpretation. This important topic will generate interest in this issue and bring about the discussion and challenges with regard to assessing the safety of these cutting-edge biotherapeutic modalities. Our panel of experts will begin by providing a brief overview of protein engineering technologies used in the design of dual-targeting biotherapeutics with the aim of providing a basic understanding of the technologies and particularly the toxicology-relevant aspects of construct design, such as the influence of amino acid sequence homology and glycosylation patterns on species-relevant pharmacologic action. We will follow the introduction with a series of three case studies that illustrate the unique issues faced when developing clinical trial-enabling strategies, study design, and data interpretation. Finally, a brief commentary from the regulatory perspective on the need for nonclinical safety and regulatory scientists to partner when faced with these new challenges will close out the session. At the conclusion of the session a summary of the challenges and proactive commentary on the future directions of nonclinical safety assessment of dual-targeting biotherapeutics will be presented. • Dual Target Construct Engineering for Target Specificity and Efficacy. Jennifer Cochran, Stanford University, Palo Alto, CA. • Nonclinical Assessment of Bispecific T Cell-Engaging Antibodies. Benno Rattel, Micromet AG, Munich, Germany. • Computational, Safety, and Regulatory Strategies Used in Developing a Novel Bispecific Molecule in Oncology. Kenneth Olivier, Merrimack Pharmaceuticals, Inc., Cambridge, MA. • Nonclinical Characterization of a HER3 and EGFR Dual Action Antibody in Cynomolgus Monkeys. Rodney Prell, Genentech, South San Francisco, CA. • Regulatory Perspective on Dual-Targeting Biotherapeutics: Approaches, Translation of Nonclinical Findings, Challenge. Anne Pilaro, US FDA, Washington, DC. • Challenges and Future Directions of Multitargeting Biotherapeutic Approaches. Warren Ku, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT. Symposia The Allergenicity and Immunomodulatory Effect of Food Substances Wednesday, March 14, 9:00 AM to 11:45 AM Chairperson(s): Greg Ladics, DuPont Agricultrual Biotechnology, Wilmington, DE, and Reiko Teshima, National Institute of Health Sciences Japan, Tokyo, Japan. Sponsor: Immunotoxicology Specialty Section Endorsed by: Food Safety Specialty Section A food allergy is a reaction of the immune system to an otherwise harmless protein in food. Typically, such food allergic reactions are mediated by IgE and occur in atopic individuals who are genetically predisposed to allergy and who have been previously sensitized to the allergen. The incidence of food allergy ranges from approximately 1%–2% in adults and 6%–8% in children. The normal immune response to dietary proteins is associated with the induction of oral tolerance, a state of active inhibition of immune responses to an antigen by means of prior exposure to that antigen via the oral route. The mechanism(s) responsible for the development of oral tolerance are still the subject of research and debate. This symposium will present several hypotheses regarding the role that dietary triglycerides and synbiotics may play in the development of oral tolerance as well as the role immunomodulating factors (e.g., environmental factors) may play in breaking oral tolerance to protein allergens. Additionally, the structural and functional biology of allergenic food proteins will be discussed along with in vitro models to predict the potential crossreactivity of food proteins. • Structural and Functional Biology of Allergenic Food Proteins. Heimo Breiteneder, Medical University of Vienna, Vienna, Austria. • Food Allergy and the Role of Dietary Triglycerides in Sensitization and Anaphylaxis against Dietary Antigens. Erik Eckhardt, University of Kentucky, Lexington, KY. • Antiallergic Effects of a Specific Mixture of Oligosaccharides or Combined with a Probiotic Strain (Synbiotics). Leon Knippels, Danone Research, Wageningen, Netherlands. • Food Sensitization and Its Induction by Immunomodulating Factors. Tomoko Shindo, Hatano Research Institute, Hadano Kanagawa, Japan. • In Vitro Provocation Study. Ryosuke Nakamura, National Institute of Health Sciences, Tokyo, Japan. Scientific up-to-date information at www.toxicology.org 79 Thematic Session
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Monday, March 12 8:00 AM-9:00 AM PL
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9:00 AM-12:30 PM Poster Sessions
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Appreciates the Generous 51st Annua
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51st Annual Meeting & ToxExpo - Society of Toxicology

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